Summary of findings 8. Dronedarone compared to placebo or no treatment for maintaining sinus rhythm after cardioversion of atrial fibrillation.
| Dronedarone compared to placebo or no treatment for maintaining sinus rhythm after cardioversion of atrial fibrillation | ||||||
| Patient or population: adults in sinus rhythm after cardioversion of atrial fibrillation Setting: hospital/community Intervention: dronedarone Comparison: placebo or no treatment | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | № of participants (studies) | Certainty of the evidence (GRADE) | Comments | |
| Risk with placebo or no treatment | Risk with dronedarone | |||||
| All‐cause mortality follow‐up: range 6–12 months | Study population | RR 0.86 (0.68 to 1.09) | 6071 (3 RCTs) | ⊕⊕⊕⊕ High | — | |
| 51 per 1000 | 44 per 1000 (35 to 56) | |||||
| Withdrawals due to adverse effects follow‐up: range 6–12 months | Study population | RR 1.58 (1.34 to 1.85) | 6071 (3 RCTs) | ⊕⊕⊕⊝ Moderatea | — | |
| 77 per 1000 | 122 per 1000 (104 to 143) | |||||
| Proarrhythmia follow‐up: mean 12 months | Study population | RR 1.95 (0.77 to 4.98) | 5872 (2 RCTs) | ⊕⊕⊕⊝ Moderateb | — | |
| 18 per 1000 | 36 per 1000 (14 to 91) | |||||
| Stroke follow‐up: mean 12 months | Study population | RR 0.66 (0.47 to 0.95) | 5872 (2 RCTs) | ⊕⊕⊕⊕ High | — | |
| 27 per 1000 | 18 per 1000 (13 to 25) | |||||
| Recurrence of atrial fibrillation follow‐up: range 6–12 months | Study population | RR 0.85 (0.80 to 0.91) | 1443 (2 RCTs) | ⊕⊕⊕⊝ Moderatec | — | |
| 76.6 per 100 | 65.1 per 100 (61.3 to 69.7) | |||||
| *The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; RCT: randomised controlled trial; RR: risk ratio. | ||||||
| GRADE Working Group grades of evidence High certainty: we are very confident that the true effect lies close to that of the estimate of the effect. Moderate certainty: we are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low certainty: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect. Very low certainty: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect. | ||||||
aDowngraded one level for study limitations: 83% of weight came from a study with unclear blinding, which could be relevant to this outcome. bDowngraded one level for inconsistency due to very high I2 statistic of 78%. cDowngraded one level for study limitations: most weight came from a study with unclear allocation concealment.